RecruitingObservational

A Prospective Study of Whole Genome Sequencing (ChromoSeq®) at Diagnosis for Pediatric, Adolescent, and Young Adult Acute Lymphoblastic Leukemia (ALL) Patients

NCT ID: NCT07313592Sponsor: Washington University School of MedicineLast updated: 2026-06-10

Summary

This is a prospective specimen collection study evaluating the feasibility of using the ChromoSeq® assay for upfront classification in a real-time clinical setting of pediatric and young adult acute lymphoid leukemia (ALL) patients. Sixty patients will undergo collections of bone marrow and/or peripheral blood for the ChromoSeq® assay at time of initial workup, and the patients will then be followed for clinical outcomes for up to 65 months.

Arms & interventions

DeviceChromoSeq® assay testing
Bone marrow and/or peripheral blood sample will be collected and ChromoSeq® assay testing will be completed.

Outcome measures

Primary

Rate of success of ChromoSeq®
ChromoSeq® will be successful if the results on the first attempt in a real-time, clinical setting identifies recurrent structural variants and copy number alterations of conventional cytogenetics and karyotype. The success rate and the 95% confidence interval will be calculated.
Time frame: Time of specimen collection to completion of results (total estimated time is 15 days)

Secondary

Comparison of time-to-results of ChromoSeq® and conventional cytogenetics
Time frame: Time of specimen collection to 15 days after collection (total estimated time is 15 days)
Frequency of mismatch between LDA standard testing and ChromoSeq® defined Ph-like patients.
Time frame: Time of specimen collection to completion of LDA testing (total estimated time is 15 days)

Eligibility criteria

Sex: AllAge: Up to 30 YearsHealthy volunteers: No

Eligibility Criteria * Children and young adult patients (\< 30 years of age at time of study enrollment) treated at St. Louis Children's Hospital/Washington University School of Medicine. * Suspected diagnosis or suspected relapse of acute lymphoblastic leukemia (ALL), B- or T-cell. * Concurrent enrollment on a prospective therapeutic trial is allowed as this protocol makes no recommendations regarding treatment approach. * Ability to understand and willingness to sign an IRB approved written informed consent document. All patients and/or their parents or legal guardians must sign an IRB approved written informed consent document.

Study locations (1)

Washington University School of Medicine/St. Louis Children's Hospital

St Louis, Missouri, 63110

Recruiting

Margaret Ferris, MD, PhD · Contact

314-454-6018 youngm@wustl.edu

Margaret Ferris, MD, PhD · Principal Investigator

Feng Gao, PhD · Sub Investigator